Low Back PainNCT00804089
Traditional Acupuncture and Myofascial Trigger Point Dry Needling and Acupressure for Chronic Low Back Pain
A study testing Traditional needle acupuncture, Myofascial trigger point dry needling and Myofascial trigger point acupressure in people with Low Back Pain, run by Hermano Miguel Foundation at 2 sites in Ecuador.
Trial summary
The purpose of this study is to compare the therapeutic effects of acupuncture using traditional acupoints and Ashi points with myofascial trigger points superficial dry needling and acupressure, followed by postisometric stretching of the appropriate muscles, in the treatment of patients with chronic mechanical low… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Traditional needle acupuncture, Myofascial trigger point dry needling and Myofascial trigger point acupressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesEcuador
- Study dates
- Dec 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of mechanical lower back pain for at least three months.
- The chronic mechanical lower back pain is the chief complaint, with or without leg pain.
- The lower back pain is disabling to the degree that affects the patient's routine job and/or his or her lifestyle.
Who cannot join
- Patients with tumor, infection, major trauma to the spine causing fracture or disruption of the major ligaments, or cauda equina syndrome.
- Patients with neurological signs of spinal nerve compression.
- Patients having undergone spinal surgery, facet joint block and/or corticoid injection.
- Patients with general contraindications for acupuncture or acupressure treatment.
Trial locations and contacts
2 sites in 1 country.
Sergiy Voznesenskyy, Ph.D. B.P.T. contact
Ecuador2 sites, 2 recruiting
- Recruiting
Social Security Hospital
Ambato, Tungurahua Province
- Recruiting
Social Security Hospital
Ibarra, Imbabura
About this study
Official title: Randomised Comparative Pragmatic Clinical Trial of Traditional Acupuncture and Superficial Dry Needling and Acupressure of Myofascial Trigger Points for the Treatment of Patients With Chronic Mechanical Low Back Pain
The purpose of this study is to compare the therapeutic effects of acupuncture using traditional acupoints and Ashi points with myofascial trigger points superficial dry needling and acupressure, followed by postisometric stretching of the appropriate muscles, in the treatment of patients with chronic mechanical low back pain.
- Conditions
- Low Back Pain
- Being tested
- Traditional needle acupuncture, Myofascial trigger point dry needling, Myofascial trigger point acupressure
- Keywords
- Low Back Pain, Chronic, Acupuncture, Dry Needling, Acupressure, Acupuncture Points, Trigger Points, Myofascial
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional needle acupunctureProcedure or surgery
Traditional needle acupuncture using traditional meridian acupoints and Ashi (tender) points
Myofascial trigger point dry needlingProcedure or surgery
Superficial dry needling of myofascial trigger points found in the muscles related to low back pain, followed by their postisometric stretching
Myofascial trigger point acupressureProcedure or surgery
Blunt needle acupressure of myofascial trigger points found in the muscles related to low back pain, followed by their postisometric stretching
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Traditional needle acupuncture Receives: Procedure: Traditional needle acupuncture |
| 2 | Active comparator | Myofascial trigger point dry needling Receives: Procedure: Myofascial trigger point dry needling |
| 3 | Active comparator | Myofascial trigger point acupressure Receives: Procedure: Myofascial trigger point acupressure |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hermano Miguel Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Ecuadorian Federation of Physiotherapy, Tungurahua Branch, Technical University of Ambato
- Investigators
- Sergiy Voznesenskyy, Ph.D. B.P.T., Principal investigator, Hermano Miguel Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804089
- Sponsor's protocol ID
- AR1-001-2008
- Status last verified
- Dec 2008
- First submitted
- 5 Dec 2008
- Last updated
- 8 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Comparative Pragmatic Clinical Trial of Traditional Acupuncture and Superficial Dry Needling and Acupressure of Myofascial Trigger Points for the Treatment of Patients With Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT00804089
- Acronym / sponsor ID
- AR1-001-2008
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Chronic, Acupuncture, Dry Needling, Acupressure, Acupuncture Points, Trigger Points, Myofascial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hermano Miguel FoundationUniversity, hospital or other
- Collaborators
- Ecuadorian Federation of Physiotherapy, Tungurahua Branch, Technical University of Ambato
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (estimated)
- First posted
- 8 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the therapeutic effects of acupuncture using traditional acupoints and Ashi points with myofascial trigger points superficial dry needling and acupressure, followed by postisometric stretching of the appropriate muscles, in the treatment of patients with chronic mechanical low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Traditional needle acupunctureTraditional needle acupuncture |
| 2 | Active comparator | Procedure: Myofascial trigger point dry needlingMyofascial trigger point dry needling |
| 3 | Active comparator | Procedure: Myofascial trigger point acupressureMyofascial trigger point acupressure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of mechanical lower back pain for at least three months.
- The chronic mechanical lower back pain is the chief complaint, with or without leg pain.
- The lower back pain is disabling to the degree that affects the patient's routine job and/or his or her lifestyle.
Key exclusion criteria (4 listed)
- Patients with tumor, infection, major trauma to the spine causing fracture or disruption of the major ligaments, or cauda equina syndrome.
- Patients with neurological signs of spinal nerve compression.
- Patients having undergone spinal surgery, facet joint block and/or corticoid injection.
- Patients with general contraindications for acupuncture or acupressure treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional needle acupunctureTraditional needle acupuncture using traditional meridian acupoints and Ashi (tender) points | Procedure or surgery | 1 |
| Myofascial trigger point dry needlingSuperficial dry needling of myofascial trigger points found in the muscles related to low back pain, followed by their postisometric stretching | Procedure or surgery | 2 |
| Myofascial trigger point acupressureBlunt needle acupressure of myofascial trigger points found in the muscles related to low back pain, followed by their postisometric stretching | Procedure or surgery | 3 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergiy Voznesenskyy, Ph.D. B.P.T. contact
Sergiy Voznesenskyy, Ph.D. B.P.T. principal investigator
Hermano Miguel Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional needle acupuncture, Myofascial trigger point dry needling and Myofascial trigger point acupressure in people with Low Back Pain, run by Hermano Miguel Foundation at 2 sites in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergiy Voznesenskyy, Ph.D. B.P.T. ((+593 2) 237 8374), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2008.